← Back to Search

Fluorescent Dye

NIR Fluorescence-Guided Surgery for Early Stage Lung Cancer

Phase 1

Recruiting

Led By Waël C. Hanna, MDCM, MBA, FRCSC

Research Sponsored by St. Joseph's Healthcare Hamilton

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

CT-imaging confirming that the tumour is confined to the one broncho-pulmonary segment, rendering the patient a candidate for segmental resection.

Tumor size <3 cm

Must not have

Women who are currently pregnant or are breast feeding; or women of child bearing potential who are not currently taking adequate birth control.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing a new way to do a surgery called a segmentectomy. Segmentectomy is hard to do robotically because it is difficult to view the tissue lines that separate each segment within the lobe. The new method uses Near-Infrared Fluorescence (NIF) to make it easier to see which pieces of tissue should be removed.

Who is the study for?

This trial is for adults over 18 with early-stage non-small cell lung cancer (NSCLC), specifically Clinical Stage 1, where the tumor is less than 3 cm and confined to a single segment of the lung. It's not suitable for those allergic to indocyanine green or iodine, nor for pregnant or breastfeeding women without effective birth control.

What is being tested?

The study tests a surgical technique called Near-Infrared Fluorescence Guided Robotic Pulmonary Segmentectomy using indocyanine green dye. This aims to help surgeons remove only the affected lung segment instead of an entire lobe, preserving more healthy tissue in patients with small tumors.

What are the potential side effects?

Potential side effects may include reactions related to indocyanine green such as allergy symptoms. Surgical risks involve complications from anesthesia, bleeding, infection, and possibly extended surgery if complete tumor removal isn't achieved initially.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My CT scan shows my lung tumor is in one segment, making me eligible for a specific type of surgery.

Select...

My tumor is smaller than 3 cm.

Select...

My condition is stage 1 non-small cell lung cancer.

Select...

I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not pregnant, breastfeeding, or able to become pregnant without using birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Malignant Neoplasms

Secondary study objectives

Added value of ICG-guidance will be evaluated using Item 7 of the 7-item binary rating scale. A score of 1/7 will indicate added value of ICG-guidance

Anatomical accuracy will be evaluated using items 4, 5, and 6 of the Indocyanine Green Segmentectomy 7-Item Binary Scale. A score of 3/7 on these items will indicate success of anatomical accuracy

Learning Curve